| CTRI Number |
CTRI/2025/09/094739 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Zinc for improving taste in breast cancer chemotherapy |
|
Scientific Title of Study
|
Topical Zinc sulphate for chemotherapy-induced dysgeusia among breast
cancer patients receiving Chemotherapy:- Pilot study
patients receiving Chemotherapy- Pilot study |
| Trial Acronym |
ZnTC |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mirunalini R |
| Designation |
Associate Professor of Pharmacology |
| Affiliation |
JIPMER, Puducherry |
| Address |
Flat A,ground floor,Alpha Anugraho Appt, new st, pudupet, lawspet
Institute Block, Department of Pharmacology, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605008
India |
| Phone |
9894516090 |
| Fax |
|
| Email |
mirunalini3012@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasanth Ganesan |
| Designation |
Professor |
| Affiliation |
JIPMER, Puducherry |
| Address |
Department of Medical Oncology, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605002
India |
| Phone |
|
| Fax |
|
| Email |
pg1980@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mirunalini R |
| Designation |
|
| Affiliation |
|
| Address |
Department of Pharmacology, JIPMER, Puducherry
Pondicherry
PONDICHERRY
605002
India |
| Phone |
|
| Fax |
|
| Email |
acadcon2019@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Mirunalini R |
| Address |
Department of Pharmacology |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Mirunalini R |
JIPMER,Puducherry |
Regional Cancer Institute
Pondicherry
PONDICHERRY |
09894516090
mirunalini3012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Intervention studies, JIPMER |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Topical Zinc Sulfate |
The dispersible zinc sulphate tablet 50 mg will be reconstituted in distilled water (50 mg in 10 ml) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
patients with breast cancer
planned for curative intent therapy (neoadjuvant or adjuvant )
with epirubicin and cyclophosphamide agents during first cycle |
|
| ExclusionCriteria |
| Details |
1. Patients who had received zinc preparations within the last two
weeks of enrolment
2. Known hypersensitivity to the drug
3. Known psychiatric disorder
4. Regular alcohol intake (3 or more drinks equivalent of 45 ml of
liquor per week) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Change in taste perception by taste acuity method
Change in CiTAS score |
Baseline and two weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse drug reaction to Topical Zinc |
Over two weeks |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is yet to start the recruitment.During the second cycle, the patient will be enrolled for the study. Baseline CITAS and taste assessmentusing taste strip (details given below) will be done The participant will be advised to take the entire solution in the mouth and move it around without swallowing it. Then post procedure CITAS and taste assessment using taste strip will be done to evaluate immediate effect. To evaluate the sustained effect of zinc sulfate by swish and spit (Z-SAS), the study intervention will be given three times a day before each meal for 2 weeks and will be tested for the taste perception using CITAS and taste strip testing method during the third cycle.
Quality of life assessment The Quality of life score will be assessed by Cancer Institute quality of life scores at the baseline and at the end of study. Adverse event monitoring: The frequency of Adverse events that are possibly due to zinc sulphate will be studied. All patients will be monitored for adverse events during the study period (CTCAE version 5.0) |